Jordana G. Fein MD , Priya S. Vakharia MD , A. Paul Chous OD , Rutvi Desai OD , Fabiana Q. Silva MD , Kimberly Reed OD , Alyson J. Berliner MD, PhD , Robert Vitti MD , Charles C. Wykoff MD, PhD
{"title":"Clinical Outcomes in Neovascular Age-related Macular Degeneration with Aflibercept 8 mg in the Phase II CANDELA Study","authors":"Jordana G. Fein MD , Priya S. Vakharia MD , A. Paul Chous OD , Rutvi Desai OD , Fabiana Q. Silva MD , Kimberly Reed OD , Alyson J. Berliner MD, PhD , Robert Vitti MD , Charles C. Wykoff MD, PhD","doi":"10.1016/j.oret.2025.03.023","DOIUrl":"10.1016/j.oret.2025.03.023","url":null,"abstract":"","PeriodicalId":19501,"journal":{"name":"Ophthalmology. Retina","volume":"9 9","pages":"Pages 915-918"},"PeriodicalIF":5.7,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143780710","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Antoine Arandilla , Elodie Bousquet MD, PhD , Paul Goupillou MD
{"title":"Wide-Field Imaging of a Large Retinal Cavernous Hemangioma in a 13-Year-Old Boy","authors":"Antoine Arandilla , Elodie Bousquet MD, PhD , Paul Goupillou MD","doi":"10.1016/j.oret.2025.02.006","DOIUrl":"10.1016/j.oret.2025.02.006","url":null,"abstract":"","PeriodicalId":19501,"journal":{"name":"Ophthalmology. Retina","volume":"9 9","pages":"Page e91"},"PeriodicalIF":5.7,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143567528","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Jasmine Yaowei Ge, Alvin Wei Jun Teo, Andrew S H Tsai, Gavin Siew Wei Tan, Shu Yen Lee, Ning Cheung, Wei-Chi Wu, Yih-Shiou Hwang, Chi-Chun Lai, Hung-Da Chou
{"title":"Macular Buckle, Vitrectomy, or Combined Approach for the Management of Macular Hole Retinal Detachment: A Systematic Review and Network Meta-Analysis.","authors":"Jasmine Yaowei Ge, Alvin Wei Jun Teo, Andrew S H Tsai, Gavin Siew Wei Tan, Shu Yen Lee, Ning Cheung, Wei-Chi Wu, Yih-Shiou Hwang, Chi-Chun Lai, Hung-Da Chou","doi":"10.1016/j.oret.2025.08.020","DOIUrl":"10.1016/j.oret.2025.08.020","url":null,"abstract":"<p><strong>Topic: </strong>There is no consensus regarding management of macular hole retinal detachment (MHRD). Techniques such as trans pars plana vitrectomy (TPPV), macular buckle (MB), and combined approach have been described.</p><p><strong>Clinical relevance: </strong>To review anatomical and functional outcomes of different surgical interventions for MHRD.</p><p><strong>Methods: </strong>A systematic literature review was performed following Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines (International Prospective Register of Systematic Reviews registration number CRD42024586953). Literature search was performed in PubMed, Embase, Cochrane Library, and clinical trial databases for randomized controlled trials or retrospective comparative studies reporting MHRD outcomes until February 15, 2025. Retinal reattachment rates, macular hole closure rates, functional outcomes, and complications were assessed. Frequentist Meta-Analysis of Proportions and Bayesian Network Meta-Analysis were conducted. Study quality was assessed with Cochrane's Risk of Bias in Nonrandomized Studies of Interventions 2.0 tool and Risk of Bias Tool 2.</p><p><strong>Results: </strong>Five studies and 308 eyes were analyzed. Retinal reattachment rates were significantly higher in combined (96.9%) and MB (96.2%) versus vitrectomy (66.9%). There was no significant difference between combined and MB (P = 0.802; risk ratio [RR] = 1.03, 95% confidence interval [CI]: 0.94-1.12; τ<sup>2</sup> = 0.00, I<sup>2</sup> = 0.00; Grading of Recommendations, Assessment, Development, and Evaluation [GRADE], moderate certainty, 4 studies, 173 eyes), whereas TPPV did significantly worse relative to MB (P < 0.001; RR = 0.64, 95% CI: 0.50-0.79; τ<sup>2</sup> = 0.00, I<sup>2</sup> = 0.00; GRADE, moderate certainty, 4 studies, 233 eyes). Macular hole closure rates were highest in the combined group (86.0%; MB, 58.4%; and TPPV, 46.3%); (Combined vs. MB: P = 0.148; RR = 1.24, 95% CI: 0.88-1.61; τ<sup>2</sup> = 0.00, I<sup>2</sup> = 0.00%; GRADE, moderate certainty of evidence, 4 studies, 173 eyes); (Vitrectomy vs. MB: P = 0.158; RR = 0.73, 95% CI: 0.40-1.05; τ<sup>2</sup> = 0.00, I<sup>2</sup> = 0.00%; GRADE, low certainty of evidence, 4 studies, 233 eyes). The postoperative visual acuity improvements for MB, combined, and TPPV were a logarithm of the minimum angle of resolution of 0.533, 0.510, and 0.434, respectively.</p><p><strong>Conclusion: </strong>Our study found that procedures involving MB was associated with better retinal reattachment rates in managing MHRD with moderate certainty. Further studies are required to evaluate macular hole closure rates, visual outcomes, and retinal reattachment rates after a combined procedure.</p><p><strong>Financial disclosure(s): </strong>Proprietary or commercial disclosure may be found after the references in the Footnotes and Disclosures at the end of this article.</p>","PeriodicalId":19501,"journal":{"name":"Ophthalmology. Retina","volume":" ","pages":""},"PeriodicalIF":5.7,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144992956","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Moiz Lakhani, Angela T H Kwan, Deeksha Kundapur, Marko M Popovic, Karim F Damji, Bernard R Hurley
{"title":"Association of Anti-VEGF Therapy with Reported Ocular Adverse Events: A Global Pharmacovigilance Analysis.","authors":"Moiz Lakhani, Angela T H Kwan, Deeksha Kundapur, Marko M Popovic, Karim F Damji, Bernard R Hurley","doi":"10.1016/j.oret.2025.08.018","DOIUrl":"https://doi.org/10.1016/j.oret.2025.08.018","url":null,"abstract":"<p><strong>Objective: </strong>Anti-vascular endothelial growth factor (VEGF) therapies have transformed the management of neovascular age-related macular degeneration, diabetic macular edema, and macular edema secondary to retinal vein occlusion (RVO). This class-wide pharmacovigilance study evaluated the disproportionality of reported ocular adverse events (AEs) among anti-VEGF agents using real-world data.</p><p><strong>Design: </strong>A population-based, observational pharmacovigilance study.</p><p><strong>Participants: </strong>Reports from the FDA Adverse Event Reporting System (FAERS) database (January 2004-September 2024) for individuals treated with anti-VEGF agents.</p><p><strong>Methods: </strong>Ocular AEs were identified from FAERS, and disproportionality was assessed by comparing each anti-VEGF agent to background reporting using reporting odds ratios (RORs, 95% CI); signals were considered significant if IC<sub>025</sub>>0. Ranibizumab, aflibercept, brolucizumab, and faricimab were evaluated to compare ocular AE profiles amongst agents.</p><p><strong>Main outcome measures: </strong>Disproportionality of reported ocular AEs among anti-VEGF agents.</p><p><strong>Results: </strong>Across included patients receiving anti-VEGF agents with ocular AEs, most were female and aged 65-85 years. When comparing intraocular inflammation (IOI) signals across anti-VEGF agents, the strongest association was observed with brolucizumab (ROR=633.32), followed by faricimab (ROR=156.44), aflibercept (ROR=51.29), and ranibizumab (ROR=16.90). Faricimab was notably associated with elevated disproportionality signals for reports of anterior segment inflammation, including anterior chamber flare (ROR=270.95), unspecified anterior chamber inflammation (ROR=226.28), iridocyclitis (ROR=214.60), and iritis (ROR=88.90). For posterior segment involvement, increased reporting of vitritis was observed with brolucizumab (ROR=1769.33), faricimab (ROR=466.99), aflibercept (ROR=165.31), and ranibizumab (ROR=56.67), Rare but clinically significant complications were reported across all agents, including for reports of endophthalmitis (aflibercept ROR=208.88, ranibizumab ROR=114.69, faricimab ROR=99.75, brolucizumab ROR=56.15), non-infectious endophthalmitis (aflibercept, ROR=846.11, 244.42 for brolucizumab, 65.45 for ranibizumab, and 59.08 for faricimab), and pseudoendophthalmitis, which showed the strongest signal with faricimab (ROR=262.31; all 95%CI=29.37-649.50, P<0.0001, IC<sub>025</sub>>0). Faricimab also demonstrated increased reporting of retinal vascular inflammation but showed comparatively lower signals for non-inflammatory occlusive events and other serious ocular complications relative to other anti-VEGF agents.</p><p><strong>Conclusions: </strong>This global pharmacovigilance study revealed variability in ocular AE reporting across anti-VEGF agents. Brolucizumab showed the strongest signal for intraocular inflammation, while aflibercept showed the highest ","PeriodicalId":19501,"journal":{"name":"Ophthalmology. Retina","volume":" ","pages":""},"PeriodicalIF":5.7,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144992642","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Carl J. Danzig MD, FASRS , Christiana Dinah MRes, FRCOphth , Faruque Ghanchi MBBS, FRCOphth , Lars-Olof Hattenbach MD, PhD , Arshad M. Khanani MD, MA , Timothy Y.Y. Lai MD, FRCOphth , Masahiko Shimura MD, PhD , Francis Abreu PhD , Pablo Arrisi PhD , Ying Liu PhD , Liliana P. Paris MD, PhD , Anne-Cecile Retiere PharmD , Jeffrey R. Willis MD, PhD , Patricio G. Schlottmann MD
{"title":"Faricimab Treat-and-Extend Dosing for Macular Edema Due to Retinal Vein Occlusion","authors":"Carl J. Danzig MD, FASRS , Christiana Dinah MRes, FRCOphth , Faruque Ghanchi MBBS, FRCOphth , Lars-Olof Hattenbach MD, PhD , Arshad M. Khanani MD, MA , Timothy Y.Y. Lai MD, FRCOphth , Masahiko Shimura MD, PhD , Francis Abreu PhD , Pablo Arrisi PhD , Ying Liu PhD , Liliana P. Paris MD, PhD , Anne-Cecile Retiere PharmD , Jeffrey R. Willis MD, PhD , Patricio G. Schlottmann MD","doi":"10.1016/j.oret.2025.03.005","DOIUrl":"10.1016/j.oret.2025.03.005","url":null,"abstract":"<div><h3>Purpose</h3><div>To assess the efficacy, durability, and safety of dual angiopoietin-2/VEGF inhibition with faricimab dosed per a modified treat-and-extend-based regimen in patients with retinal vein occlusion.</div></div><div><h3>Design</h3><div>Single-arm treatment period after a randomized, double-masked, active comparator-controlled period in the phase III BALATON/COMINO (NCT04740905/NCT04740931) trials.</div></div><div><h3>Participants</h3><div>Patients with treatment-naïve foveal center-involved macular edema due to branch (BALATON; N = 553) or central/hemiretinal (COMINO; N = 729) retinal vein occlusion.</div></div><div><h3>Methods</h3><div>Patients randomized to faricimab 6.0 mg every 4 weeks (Q4W) or aflibercept 2.0 mg Q4W up to week 20 received faricimab 6.0 mg dosed per a modified treat-and-extend-based regimen from week 24 to 72. The dosing frequency was adjusted from Q4W to Q16W based on changes in central subfield thickness (CST) and best-corrected visual acuity.</div></div><div><h3>Main Outcome Measures</h3><div>Change from baseline through week 72 in best-corrected visual acuity and CST; durability and safety through week 72.</div></div><div><h3>Results</h3><div>Visual acuity gains and CST reductions achieved at week 24 were maintained through week 72. Adjusted mean best-corrected visual acuity (95.03% confidence interval [CI]) changes from baseline averaged over weeks 64, 68, and 72 in the prior faricimab Q4W and prior aflibercept Q4W arms were +18.1 letters (16.9–19.4) and +18.8 letters (17.5–20.0), respectively, in BALATON and +16.9 letters (15.2–18.6) and +17.1 letters (15.4–18.8), respectively, in COMINO. Adjusted mean (95.03% CI) CST changes from baseline averaged over weeks 64, 68, and 72 in the prior faricimab Q4W and prior aflibercept Q4W arms were −310.9 μm (−315.6 to −306.3) and −307.0 μm (−311.7 to −302.3), respectively, in BALATON and −465.9 μm (−472.5 to −459.3) and −460.6 μm (−467.2 to −453.9), respectively, in COMINO. In the prior faricimab Q4W and prior aflibercept Q4W arms, 64.1% and 56.9% of patients from BALATON and 45.5% and 50.1% from COMINO, respectively, were on ≥Q12W dosing at week 68. Faricimab continued to be well tolerated from weeks 24 to 72; the safety profile was consistent with that established for diabetic macular edema and neovascular age-related macular degeneration.</div></div><div><h3>Conclusions</h3><div>These findings support the sustained efficacy and safety of faricimab in patients with macular edema due to retinal vein occlusion up to 72 weeks, with the potential for reduced treatment burden due to response durability.</div></div><div><h3>Financial Disclosure(s)</h3><div>Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.</div></div>","PeriodicalId":19501,"journal":{"name":"Ophthalmology. Retina","volume":"9 9","pages":"Pages 848-859"},"PeriodicalIF":5.7,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143664058","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
David H. Abramson MD , Jasmine H. Francis MD , Jared Knopman MD , Ira J. Dunkel MD , Yves Pierre Gobin MD
{"title":"Ophthalmic Artery Chemosurgery for Retinoblastoma Babies Less than 3 Months Old or under 6-kg Weight","authors":"David H. Abramson MD , Jasmine H. Francis MD , Jared Knopman MD , Ira J. Dunkel MD , Yves Pierre Gobin MD","doi":"10.1016/j.oret.2025.03.008","DOIUrl":"10.1016/j.oret.2025.03.008","url":null,"abstract":"<div><h3>Objective</h3><div><span>To determine the feasibility, safety, and efficacy of ophthalmic artery </span>chemosurgery<span><span> (OAC) for very young children who have unilateral and bilateral </span>retinoblastoma.</span></div></div><div><h3>Design</h3><div>Retrospective, consecutive review of all children with retinoblastoma (unilateral and bilateral) treated with OAC in the first 3 months of life or, if weighing <6 kg, treated at the Memorial Sloan Kettering Cancer Center.</div></div><div><h3>Participants</h3><div>All children with retinoblastoma (unilateral or bilateral) treated with OAC (17 patients) in the first 3 months of life or weighing <6 kg.</div></div><div><h3>Methods</h3><div>Ophthalmic artery chemosurgery delivered by microcatheter inserted in the femoral artery<span><span> and through the internal carotid artery<span><span>. Combinations of melphalan, </span>carboplatin, and </span></span>topotecan were delivered in 60 sessions via the ophthalmic artery in 17 patients.</span></div></div><div><h3>Main Outcome Measures</h3><div><span>Ocular salvage, serial electroretinograms, patient survival, second cancers, fever/neutropenia, transfusion of any blood product, groin bleeding or femoral artery occlusion, and </span>anesthetic complications.</div></div><div><h3>Results</h3><div><span>Seventeen retinoblastoma patients under the age of 3 months or weighing <6 kg were successfully canulated and treated a total of 60 times (11 bilateral patients and 6 unilateral patients) with combinations of Melphalan, Carboplatin, and Topotecan. All patients are alive; the mean follow-up 4 years. No patient developed metastatic disease, second cancer, or trilateral retinoblastoma and all eyes were salvaged. There were no cases of chemotherapy induced fever/neutropenia or need for transfusion of any blood product. Electroretinogram was not impaired by treatment, significant improvement in 30Hz function was seen (</span><em>P</em> = 0.02; mean before 61 μV, after 71 μV, SEM: 5.25 vs. 5.82).</div></div><div><h3>Conclusions</h3><div>Very young children (<3 months old and <6 kg weight) with unilateral or bilateral retinoblastoma can be safely and effectively treated with OAC (intra-arterial chemotherapy) without significant complications even though the majority had advanced intraocular disease (Reese-Ellsworth Vb or International Classification of Retinoblastoma “D” and “E”). This includes treating both eyes in the same session and as young as 5 weeks and weighing 3.6 kg. This eliminates the need for systemic chemotherapy, which is well known to be toxic to the youngest children.</div></div><div><h3>Financial Disclosure(s)</h3><div>Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.</div></div>","PeriodicalId":19501,"journal":{"name":"Ophthalmology. Retina","volume":"9 9","pages":"Pages 908-914"},"PeriodicalIF":5.7,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143693079","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Jordi Monés MD, PhD , Fernando Pagani MD , Juan Francisco Santmaría MD , Míriam Garcia OD , Cristina Romero OD , Daniel Garcia OD , Anna Serrano RN , Alícia Carrasco RN
{"title":"Spontaneous Soft Drusen Regression without Atrophy and the Drusen Ooze","authors":"Jordi Monés MD, PhD , Fernando Pagani MD , Juan Francisco Santmaría MD , Míriam Garcia OD , Cristina Romero OD , Daniel Garcia OD , Anna Serrano RN , Alícia Carrasco RN","doi":"10.1016/j.oret.2025.02.023","DOIUrl":"10.1016/j.oret.2025.02.023","url":null,"abstract":"<div><h3>Objective</h3><div>To determine the incidence of spontaneous soft drusen (SD) regression without atrophy (DRwoA) in patients with intermediate or atrophic age-related macular degeneration (AMD), evaluate associated events, and offer potential explanations.</div></div><div><h3>Design</h3><div>A retrospective review of the imaging of a consecutive series of 640 eyes from 320 patients with AMD who had ≥2 years of follow-up.</div></div><div><h3>Subjects</h3><div>Four hundred twenty-seven eyes from 262 patients with intermediate AMD or atrophic AMD and no present or past exudative AMD.</div></div><div><h3>Methods</h3><div>Retinal imaging included infrared reflectance imaging, fundus autofluorescence, spectral-domain OCT, and color fundus photography.</div></div><div><h3>Main Outcome Measures</h3><div>The outcomes included drusen regression without atrophy with integrity of the retinal pigment epithelium (RPE) and repositioning over Bruch’s membrane. In addition, drusen that would collapse with atrophy (DCwA) in the same area simultaneously were named “sentinel” DCwA. The outcomes also included the reversibility of features of incomplete RPE, outer retinal atrophy (iRORA), and the areas (“halos”) of DRwoA around the “sentinel” drusen.</div></div><div><h3>Results</h3><div>Among the 427 eyes, 53 events of DRwoA were found, representing 24.17% of the eyes with SD. In 50 cases (94.33%), a “sentinel” DCwA in the vicinity was found. In 58% of the cases, a well-identifiable halo of drusen disappearance around the “sentinel” DCwA was well visible.</div></div><div><h3>Conclusions</h3><div>Drusen regression without atrophy is a frequently observed phenomenon linked to SD and almost invariably occurs near a “sentinel” DCwA. The coalescence of the drusen and the spatial and temporal association of the DRwoA and the DCwA strongly suggest that the drusen material of DRwoA escapes to a contiguous “sentinel” DCwA. Although the hypothesis of the disappearance of drusen material due to RPE death may explain the DCwA, it fails to account for DRwoA. Instead, the “drusen ooze” hypothesis, which posits the movement of drusen content to the subretinal space through RPE defects, may explain both the DCwA and the DRwoA. This hypothesis offers insights into the reversibility of iRORA features and suggests that therapies targeting drusen material removal before RPE disruptions could potentially prevent atrophy secondary to SD collapse.</div></div><div><h3>Financial Disclosure(s)</h3><div>Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.</div></div>","PeriodicalId":19501,"journal":{"name":"Ophthalmology. Retina","volume":"9 9","pages":"Pages 828-837"},"PeriodicalIF":5.7,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143537494","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}